This is a guest editorial written by Maryland injury lawyer Austin Kirk, whose firm is investigating potential Avandia lawsuits for users throughout the United States. To speak with Mr. Kirk, call 1 (800) 522-0102
Over the past 18 months, a number of studies and reports have emerged which raise concerns about the safety of Avandia (rosiglitazone), and whether the drug should continue to remain on the market.
Last week, the consumer advocacy group Public Citizen filed a petition with the FDA asking the agency to issue an Avandia recall, indicating that the evidence against this once-popular type 2 diabetes drug is “overwhelming”.
The petition, which was filed on behalf of more than 80,000 consumers nationwide, called for an immediate Avandia ban as a result of “clear previous evidence of increased risk of heart attacks, heart failure, bone fractures, anemia and macular (retinal) edema with vision loss.”
Public Citizen also pointed to new evidence from an analysis they performed, which identified 14 cases of liver failure associated with Avandia, 12 of which resulted in death.
Health concerns surrounding the drug first emerged in May 2007, leading the FDA to issue an Avandia safety alert stating that studies show there is a “potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”
In November 2007, the FDA and GlaxoSmithKline announced that new language would be added to a ‘black box’ warning on the Avandia label about the potential heart attack risk. However, during the months leading up to this announcement, there was fierce internal debate within the FDA about whether to allow the drug to stay on the market. An FDA drug-safety oversight board narrowly voted against an Avandia recall 8 to 7.
In addition to the Public Citizen petition, there have been a series of developments over the past few months which make it appear likely that the FDA will revisit their decision about Avandia and consider withdrawing approval for the medication.
In August 2008, an editorial was published online by the medical journal Heart, in which researchers from Wake Forest University School of medicine questioned the rationale for leaving Avandia on the market, citing the serious side effects associated with the drug.
In addition, last month the American Diabetes Association and European Association for the Study of Diabetes dropped Avandia from their consensus statements on type 2 diabetes treatments, recommending against use of the drug.